Kornimate/medical-research-clean huggingface dataset:
18f-dcfpyl positron emission tomography (pet) in intermediate or high risk prostate cancer

Conditions: Prostate Cancer

Summary: this is an interventional, single group assignment, prospective nonrandomized, open label phase 2 trial designed to evaluate 18f-dcfpyl pet imaging in men diagnosed with prostate cancer with increasing prostate-specific antigen (psa) levels.

this is an trial designed to evaluate the positive predictive value of 18f-dcfpyl pet imaging in men diagnosed with prostate cancer with increasing psa levels. patients will receive a single dose of 18fdcfpyl pet and undergo a pet imaging study. 18f-dcfpyl injection is an 18f-labeled small molecule that targets the extracellular domain of psma. one intravenous catheter will be placed for radiopharmaceutical administration. patients will be injected with ≤ 333 mbq (≤ 9 mci) of 18f-dcfpyl via this catheter. the dose range for 18f-dcfpyl will be 7 - 9 mci. the pet imaging may be repeated at a later date if the biopsy of the lesion is negative and if the lesion is present on follow-up imaging.

Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of prostate cancer * biochemical recurrence was defined as a psa of 0.2 or more ng/ml measured more than 6 weeks after prostatectomy or a psa of 2 or more ng/ml rise above nadir following radiation therapy (astro phoenix consensus definition) * age ≥ 18 years of age * eastern cooperative oncology group (ecog) performance status ≤ 2 (karnofsky ≥ 60%) * ability to understand and willingness to sign a written informed consent document * willing to comply with clinical trial instructions and requirements exclusion criteria: * history of another active malignancy within 3 years, other than basal cell and squamous cell carcinoma of the skin * presence of prostate brachytherapy implants unless approved by the pi * administration of another radioisotope within five physical half-lives of trial enrollment * radiation or chemotherapy within 2 weeks prior to trial enrollment * estimated glomerular filtration rate (egfr) \< 15 ml/mmol * serum total bilirubin \> 3 times the upper limit of normal * aspartate transaminase (ast) or alanine aminotransferase (alt) \> 5 times the upper limit of normal * inadequate venous access * claustrophobia or any other condition that would preclude pet imaging * patients must not be receiving adt except per criteria directly below. patients who received in the past must have a serum testosterone that is recovered to at least 100 ng/dl. * patients who have been on adt +/- novel hormonal agent (nha) and developed m0 crpc
european study of cardiovascular risk

Conditions: Cardiovascular Risk Factors; Hyperlipidemia; Hypertension; Diabetes; Obesity; Smoking

Summary: the main objective of this study is to describe the management of patients with cardiovascular risk factors in primary prevention among different european countries. the patient's participation consists of a single study visit during a routine visit of the patient to the clinic/office. study variables will be measured: * by an interview between physician and patient during the visit and/or available medical records' information: social and demographic patient characteristics, relevant family medical history, current medication. * by questions asked to the physician: physician perception of patients' cv risk factor, guidelines adherence and cost-containment. * by measurement performed to the patient during the visit: weight, height, bmi, waist and hip circumference will be measured. * cv risk factors (blood parameters) will be measured by collecting available data documented within the last year in the medical records and by the collection and analyses of a blood sample during the visit.


Eligibility criteria:
inclusion criteria: * provision of informed consent. * patients 50+ years old, with at least one additional cv risk factor (with no previous cv event or hospitalisation for a cv event) from primary care or hospital outpatient clinic. exclusion criteria: * subjects who are unwilling or unable to provide informed consent * previous cv disease event or hospitalisation for a cv event * current participation in a clinical trial

Keywords: cardiovascular risk management hyperlipidemia hypertension diabetes obesity
study of pm060184 in patients with advanced solid tumors

Conditions: Solid Tumors

Summary: the purpose of the study is to determine the maximum tolerated dose and the recommended dose and to evaluate the safety and tolerability of pm060184.

this trial intends to determine the maximum tolerated dose and the recommended dose, to evaluate the safety and tolerability, to determine the pharmacokinetics and to evaluate the antitumor activity of pm060184 in patients with advanced solid tumors.

Eligibility criteria:
inclusion criteria 1. voluntary signed and dated written informed consent. 2. patients with advanced solid tumors refractory to standard therapy. 3. age \>/= 18 years. 4. recovery from drug-related adverse events (aes) of previous treatments, excluding alopecia. 5. normal laboratory values within seven days prior to treatment administration. 6. women of childbearing potential must have a negative serum pregnancy test before study entry. both men and women must agree to use a medically acceptable method of contraception throughout the treatment period and for three months after discontinuation of treatment. exclusion criteria 1. pregnant or lactating women. 2. less than three weeks from radiation therapy or last dose of hormonal therapy, biological therapy or chemotherapy 3. prior treatment with any investigational product less than 30 days prior to the first. 4. central nervous system metastases 5. other relevant diseases or adverse clinical conditions: * increased cardiac risk: * presence of significant neurological or psychiatric disorders * neuropathy * active infection requiring treatment. * liver disease (e.g., cirrhosis, hepatitis). * immunocompromised patients. * any other major illness. 6. limitation of the patient's ability to comply with the treatment. 7. known hypersensitivity to any of the components of the drug product.

Keywords: pm060184 phase i pharma mar
efficacy of oral probiotic administration in patients with chronic periodontitis

Conditions: -Chronic Periodontitis

Summary: the aim of this randomized placebo- controlled clinical trial is to evaluate the effects of lactobacillus rhamnosus sp1- containing probiotic tablets as an adjunct to scaling and root planning (srp). material and methods: thirty six chronic periodontitis patients will be recruited and monitored clinically, immunologically and microbiologically at baseline, 3 and 6 months after therapy. all patients will receive scaling and root planning and randomly will be assigned over an experimental (srp + probiotic, n=18) or control (srp + placebo, n=18) group. the tablets will be used once per day during 3 months.


Eligibility criteria:
inclusion criteria: * ≥14 natural teeth, excluding third molars * ≥10 posterior teeth * ≥35 years old * ≥ 5 teeth with periodontal sites with probing depths ≥5mm, clinical attachment loss ≥3mm * bleeding on probing ≥20% of sites * extensive bone loss determined radiographically exclusion criteria: * periodontal treatment before the time of examination * systemic illness * pregnancy * anticoagulant, antibiotics and non- steroid anti- inflammatory therapy in the 6-month period before the study

Keywords: chronic periodontitis probiotics non- surgical treatment
strategies for maintenance therapies in advanced non small cell lung cancer

Conditions: Advanced Non Small Cell Lung Cancer

Summary: in france, lung cancer is responsible for more than 30000 each year. progress was made in treatment of lung cancer in the last five years due to targeted therapies and to strategical evolutions consisting in a best adjustment of treatments. maintenance strategies is one of this strategical evolution. it is based on maintaining continuous therapeutical pression in order to preserve the therapeutical benefit obtained by the first line (induction chemotherapy). several clinical trials showed that maintenance strategies increase the duration of controlled disease. there is two types of maintenance strategies: * continuous maintenance : prolongation of the treatment initially associated with platin until progression * switch maintenance : introduction of a new treatment after the end of induction chemotherapy the aim of this study is to compare two maintenance strategies * a continuous maintenance by pemetrexed * a switch maintenance or a continuous maintenance according to the response of induction chemotherapy.


Eligibility criteria:
inclusion criteria: * non-squamous nsclc histologically or cytologically confirmed * stage iv with a cytologically or histologically confirmation for an unique metastasis * no egfr activating mutation or indeterminate egfr mutational status * at least one measurable lesion * age between 18 and 70 * ps 0 or 1 exclusion criteria: * squamous cell lung cancer, small cell lung cancer , neuroendocrine cell lung cancer * knowledge of alk gene rearrangement * symptomatic central nervous system metastases or requiring immediate cerebral radiotherapy * superior venous cave syndrome except if treated by implantation of a prosthesis * previous anti-tumoral treatment * concomitant radiotherapy

Keywords: non small cell lung cancer ifct maintenance switch
study of intraoperative radiotherapy for middle and low rectal cancer

Conditions: Rectal Cancer

Summary: to study the application of intersphincteric resection（isr）combined with intraoperative radiation therapy(iort) for ultra-low rectal cancer,and to broaden the surgical indications of intersphincteric resection（isr. the study is aimed to assess the postoperative acute complication and the short-term acute efficacy on the patients with middle and low rectal cancer by treated with intraoperative radiotherapy,especially those with peritoneal inversion rectal cancer.

abstract objective: to study the application of intersphincteric resection（isr）combined with intraoperative radiation therapy(iort) for ultra-low rectal cancer,and to broaden the surgical indications of intersphincteric resection（isr）. methods: patients, who were diagnosed with ultra-low rectal cancer and had strong desire of preserving anal function, will take part in the research,whose tumor invading the levator ani muscle or above, the diameter less than 6cm, the lower tumor margin away from the anal verge by less than 5cm and away from the dentate line by less than 3cm.they will undergo total mesorectal excision(tme) and isr combined with iort and prophylactic ileostomy. outcomes measures:the evaluation of short term effects includes complications such as anastomotic leakage, acute radiation injury ,urinary dysfunction ,dysfunction of anal sphincter ,sexual dysfunction ,local recurrence , total life expectancy and expectancy without metastasis. the postoperative pathological examination reported to be moderately differentiated adenocarcinoma .we wili assess their postoperative acute complications and short-term efficacy .their time of follow up visit wil be 1 year or more.

Eligibility criteria:
inclusion criteria: inclusion criteria: * aged 40 to 80 years old, gender not limited. * be diagnosed as colorectal cancer by coloscopy. * patients with middle and low rectal cancer,whose preoperative staging evaluation is t3 ,t4 or n+. * accept surgery and intraoperative radiotherapy. * signed informed consent exclusion criteria: * the patients whose preoperative evaluation is below t3 stage with middle and rectal cancer. * active internal bleeding (such as gastrointestinal bleeding), urogenital system, or have not cure of peptic ulcer in four weeks * severe liver and kidney dysfunction * intracranial tumor, suspicious aortic dissection, arteriovenous malformation, aneurysm * thrombolysis treatment in one week * allergies of thrombolysis drug or contrast * participated in any clinical trials within three months

Keywords: ultra-low rectal cancer intersphincteric resection iort
jc virus antibody study of participants with relapsing forms of ms receiving treatment with natalizumab

Conditions: Relapsing Multiple Sclerosis

Summary: the primary objective of this study is to demonstrate that the incidence of progressive multifocal leukoencephalopathy (pml) in natalizumab-treated participants who do not have detectable antibodies to john cunningham virus (jcv) (antibody negative) is lower than in participants who have detectable antibodies to jcv (antibody positive). the secondary objectives of this study are to: estimate the incidence of pml in natalizumab-treated participants who are anti-jcv antibody negative and anti-jcv antibody positive, based on a meta-analysis of data obtained from this study and other data sources; define the prevalence of anti-jcv antibody in relapsing multiple sclerosis (ms) participants receiving natalizumab within the tysabri outreach: united commitment to health (touch) prescribing program; determine changes in anti-jcv antibody status over time.

no treatment is provided in this observational, longitudinal cohort study. study population will consist of united states (us) participants with relapsing ms receiving commercial natalizumab. there are no study-mandated visits. serum samples will be collected during routine patient care or follow-up visits and will be sent to a central laboratory for analysis (presence of anti-jcv antibody), and remaining serum aliquots will be stored for future natalizumab and pml research. additional samples will be collected at participating sites from participants who qualify and consent to participate in focused sampling group (participants who are anti-jcv antibody positive at any time point and have received ≥12 infusions of natalizumab, whether or not they have a history of immunosuppressant use). these samples will be stored for future natalizumab and pml research.

Eligibility criteria:
key inclusion criteria: * relapsing ms patients receiving commercial natalizumab * patients receiving natalizumab and their prescribers must be enrolled in the touch prescribing program. * patients with suspected or confirmed pml who are at or referred to a participating stratify-2 site may enroll into stratify-2 for purposes of pml sample collection. key exclusion criteria: - patients may participate in any other clinical trial or study sponsored by biogen idec ; however, if the anti-jcv antibody test is included in the other clinical study and that study is performing a longitudinal analysis of those samples, the patient should withdraw from stratify-2. note: other protocol defined inclusion/exclusion criteria may apply

Keywords: jcv sample collection pml antibody
to study the impact of stopping therapy in patients of cml with molecular remission

Conditions: Chronic Myeloid Leukemia; Treatment Free Remission

Summary: patients with chronic myeloid leukemia (cml) are conventionally put on life long therapy with tyrosine kinase inhibitor drugs (imatinib mesylate in india). patients who achieve a deep molecular response which has been sustained for at least three years, can be taken off the drug therapy. thereafter a close monitoring is required to monitor their disease relapse. in case there is evidence of disease recurrence on highly sensitive molecular assays, their drug therapy is restarted. the study aims to identify proportion of patients who can be kept off drug therapy in a state of sustained molecular remission.

while a large number of studies which have stopped tki therapy in similar patients exist in europe and usa, no such study has been done on indian or other south asian population. almost all studies done previously have noted that in relapsed patients, who show disease recurrence on stopping their tki therapy, their remission state is regained once the tki therapy is restarted.

Eligibility criteria:
inclusion criteria: 1. patients of cml on tki (imatinib) therapy for more than 5 years 2. patients who have been in complete molecular response (mr 4.5 +) for at least three years exclusion criteria: 1. patients who ever had blast crisis 2. patients achieving molecular response with second generation tki due to failure of imatinib

Keywords: cml, treatment free remission
effect of neck strength training on health-related quality of life in females with neck pain

Conditions: Neck Pain

Summary: the purpose of this study is to determine whether intensive one-year neck strength training can enhance health related quality of life in females with chronic neck pain.


Eligibility criteria:
inclusion criteria: * female * aged 25 to 53 years * office worker * permanently employed * motivated to continue working * motivated for rehabilitation * constant or frequently occurring neck pain for more than 6 months exclusion criteria: * severe disorders of the cervical spine * disk prolapse * spinal stenosis * postoperative conditions in the neck and shoulder areas * history of severe trauma * instability * spasmodic torticollis * frequent migraine * peripheral nerve entrapment * fibromyalgia * shoulder diseases (tendonitis, bursitis, capsulitis) * inflammatory rheumatic diseases * severe psychiatric illness and other diseases that prevent physical loading * pregnancy
exercise in sjogren, myositis and takayasu's arteritis

Conditions: Primary Sjogren´s Syndrome; Myositis

Summary: exercise may improve physical capacity and health parameters in primary syndrome´s sjogren, myositis and takayasu's arteritis. therefore, this study aims to investigate the role of an exercise training program in patients with primary syndrome´s sjogren, myositis and takayasu's arteritis.


Eligibility criteria:
inclusion criteria: * physically inactive * stable drugs regime for at least three months exclusion criteria: * other rheumatic diseases * physical disability that prevent the patient to perform the physical tests * severe pulmonary disease
routine lymphadenectomy for intrahepatic cholangiocarcinoma

Conditions: Intrahepatic Cholangiocarcinoma

Summary: the role of routine lymphadenectomy (lnd) in the surgical treatment of intrahepatic cholangiocarcinoma (icc) remains controversial. the investigators' multi-institutional retrospective study have showed an increasing adoption of lnd among patients undergoing curative resection for icc during the last decade. the current prospective and randomized study based on a multi-institutional collaboration would investigate whether routine lnd would benefit patients in short- and long-term survival remains.

intrahepatic cholangiocarcinoma (icc) is the second most common primary liver cancer and its incidence is increasing worldwide.resection of the primary icc tumor site within the liver represents the best curative treatment option. however, the role of lymphadenectomy (lnd) at the time of surgery remains controversial with some centers considering it standard while other surgeons perform lnd only in select circumstances. the utilization of lnd may not only vary among different institutions, but also by geographic region. specifically, data from east and west centers have noted a variation in the utilization of lnd ranging 27%-100%.while several case series from asia have noted that most centers do not regularly perform lnd,other data from the west suggest that lnd may be becoming more routine. despite the lack of consensus among surgeons, the american joint committee on cancer (ajcc) staging manual recommends that the nodal basin be staged. disease-specific staging for icc was first introduced in the 7th edition of the ajcc staging manual published in 2010. the newly updated 8th edition of the ajcc staging system now recommends that 6 lymph nodes be evaluated to stage a patient with icc. the previous multi-institutional retrospective study from the investigators have showed an increasing adoption of lnd among patients undergoing curative resection for icc during the last decade. the current prospective and randomized study based on a multi-institutional collaboration would investigate whether routine lnd would benefit patients in short- and long-term survival remains.

Eligibility criteria:
inclusion criteria: * patients diagnosed with intrahepatic cholangiocarcinoma by imaging or biopsy * the tumor is limited in the liver with no distant metastasis, and the primary disease is resectable * preoperative imaging (e.g. ct, mri, pet-ct, etc.) and intraoperative exploration found no nodal swelling or enlargement exclusion criteria: * the primary disease is unresectable with or without distant metastasis * the liver function or general condition of patients does not permit surgery * preoperative imaging (e.g. ct, mri, pet-ct, etc.) and intraoperative exploration found obvious nodal swelling or enlargement, which indicates lymphadenectomy should be performed * patients aged below 18 or older than 65 would be excluded * pregnant women would not be enrolled

Keywords: intrahepatic cholangiocarcinoma surgery lymphadenectomy lymph node metastasis prognosis
busulfan-fludarabine conditioning and t-cell depleted allogeneic stem cell transplantation for patients with advanced hematologic malignancies

Conditions: Leukemia; Lymphoma; Myeloma

Summary: the purpose of this study is: 1. to establish the maximally tolerated dose (mtd) of intravenous busulfan (busulfan®) in combination with fludarabine as conditioning regimen for transplantation with in-vivo t-cell depletion. 2. to evaluate disease free and overall survival after this conditioning regimen in patients with advanced acute myeloid leukemia (aml) and myelodysplastic syndromes (mds). 3. to evaluate potential pharmacogenomic determinants of toxicity of this regimen. 4. to evaluate potential pharmacogenomic determinants of efficacy of this regimen.


Eligibility criteria:
inclusion criteria: phase i portion: * relapsed or refractory acute myelogenous or lymphoid leukemia. * chronic myelogenous leukemia in accelerated phase or blast-crisis. * recurrent or refractory malignant lymphoma or hodgkin's disease * recurrent or refractory multiple myeloma. * chronic lymphocytic leukemia, relapsed or with poor prognostic features. * myeloproliferative disorder (polycythemia vera, myelofibrosis) with transformation * myelodysplastic syndromes with more than 5% blasts. phase ii portion: * aml with active disease or beyond cr2. * mds with more than 5% blasts. exclusion criteria: * clinical progression. such patients may be treated on other treatment protocols or at the investigator's discretion. such patients will continue to be monitored for survival and, may be asked to continue to provide specimens for studies of minimal residual disease and immune reconstitution as other treatments are recommended.

Keywords: cancers of the blood